NCT02834221

Brief Summary

This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

June 29, 2016

Last Update Submit

June 6, 2017

Conditions

Atrial FibrillationPeripheral Vascular DiseaseVascular Access Complications

Keywords

Femoral vein puncture

Outcome Measures

Primary Outcomes (1)

  • Major complications

    Total patient number of vascular complications requiring surgical treatment, retroperitoneal hematoma requiring blood transfusion or hemoglobin drop of 3 \>g/dl, strong pain at the groin, prolonging hospital stay and requiring hospital admission after discharge.

    After the puncture up to 12 weeks

Secondary Outcomes (5)

  • Unsuccessful femoral vein cannulation

    Immediately after the puncture

  • Number of puncture attempts

    Immediately after the puncture

  • Total puncture time

    Immediately after the puncture

  • Number of artery mis-punctures

    Immediately after the puncture

  • Use of X-ray for successful wire cannulation

    Immediately after the puncture

Study Arms (2)

Real-time ultrasound-guided puncture

EXPERIMENTAL

Cannulate each femoral veins with two wires with real-time ultrasound-guided method.

Device: Real-time ultrasound-guided puncture

Anatomical landmark guided puncture

OTHER

Cannulate each femoral veins with two wires with the anatomical landmark guided method.

Other: Anatomical landmark guided puncture

Interventions

Real-time ultrasound-guided punctureDEVICE

A 7 megahertz ultrasound linear probe will be used.

Real-time ultrasound-guided puncture
Anatomical landmark guided punctureOTHER

Anatomical landmark puncture

Anatomical landmark guided puncture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment.

You may not qualify if:

  • Patients with prior known vascular access problems or priory included to the current study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Regional Hospital Liberec

Liberec, 46001, Czechia

Location

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

Ústřední vojenská nemocnice

Prague, 16902, Czechia

Location

Kawakita General Hospital

Tokyo, 166-8588, Japan

Location

Related Publications (1)

  • Yamagata K, Wichterle D, Roubicek T, Jarkovsky P, Sato Y, Kogure T, Peichl P, Konecny P, Jansova H, Kucera P, Aldhoon B, Cihak R, Sugimura Y, Kautzner J. Ultrasound-guided versus conventional femoral venipuncture for catheter ablation of atrial fibrillation: a multicentre randomized efficacy and safety trial (ULTRA-FAST trial). Europace. 2018 Jul 1;20(7):1107-1114. doi: 10.1093/europace/eux175.

    PMID: 28575490RESULT

MeSH Terms

Conditions

Atrial FibrillationPeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Study Officials

  • Joseph Kautzner, MD, PhD

    Institute for Clinical and Experimental Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 15, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CZ(3)JP(1)